DermaTherapy Bed Linens— 510(k) K152884
Substantially EquivalentPrecision Fabrics Group, Inc.
FDA 510(k) clearance K152884 for DermaTherapy Bed Linens, Substantially Equivalent on 2016-06-20. Applicant: Precision Fabrics Group, Inc.. Device class: 1.
Clearance details
- Applicant
- Precision Fabrics Group, Inc.
- Product code
- Code FMW
- Device class
- Class 1
- Regulation
- 21 CFR 880.6190
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Greensboro, NC, US
Recent devices under product code FMW
view all- K061242 — DERMATHERAPY, MODEL 22216
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- K940327 — INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW
- K935220 — CORE PREVENT MATTRESS MODIFICATION
Data sourced from openFDA. This site is unofficial and independent of the FDA.